TemperatureNCT06778252
UrbanHEAT: Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
An observational study of Temperature, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
We are conducting a research study to learn about how individuals living in Washington, DC perceive and experience temperature. Participation in this study will include: 2 remote visits over the phone and/or computer (these will each last about1.5 to 2 hours) During the remote visits, you will be asked to respond to a… Read more about this study
- Who is it for?
- Ages 18 to 115 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 29 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 115 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults 18 and over with home addresses located within Washington, DC.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Aged at least 18 years.
- Ability to read and write in English. This is justified by the novelty of the survey instruments (e.g., momentary thermal comfort conducted in an ecological momentary assessment context).
- Home address in Washington, DC
- Availability of a smart phone on which Metricwire Ecological Momentary Assessment software can be downloaded and used during the 14-day data collection period.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Requirement of hospitalization at enrollment.
- Inability to consent.
- Unwillingness to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Minority Health and Health Disparities
Bethesda, Maryland, 20892-5465
About this study
Official title: UrbanHEAT: Pilot of Prospective Observational Study of Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
We are conducting a research study to learn about how individuals living in Washington, DC perceive and experience temperature.
Participation in this study will include:
Read more
2 remote visits over the phone and/or computer (these will each last about1.5 to 2 hours)
- During the remote visits, you will be asked to respond to a series of surveys, so that we can learn about your life, behaviors, and health 2 weeks of data collection where you will be asked to:
- Wear monitoring devices
- These will collect information on your location and physical activity
- We will ask you to wear the monitors on a belt around your waist all day every day during these 2 weeks of data collection.
- All of the monitors will be sent to you in the mail.
- Leave a temperature tracker near where you sleep to measure the temperature of your environment.
- Use a phone app
- We will also send you questions through the phone app that will ask about your stress level, sleep duration, sleep quality, and how you feel about the current temperature.
Risks of participating in this study are minimal. They include the inconvenience of wearing the monitors and the possibility of a breach of your confidentiality. We are collecting personal information about you and the location monitor will collect information about where you spend your time. We will take every precaution in order to safeguard the data that you provide, including limiting who has access to it, storing it safely, and removing the capacity to identify you individually, as much as possible.
You will receive no immediate benefits from participating in this study. We hope what we learn will help us to develop policies and programs to help keep urban populations safe during increasingly warm summer temperatures.
You are eligible for this study if you are 18 years of age or older, live in Washington, DC, can read and write in English, and have access to a smartphone that you can use for the 2 week data collection period....
Read the detailed description
Study Description:
This pilot study will test measures for cardiometabolic behaviors and outcomes (e.g., physical activity, sedentary behavior, stress, sleep quality, sleep quantity) and individually experienced temperature with intensive longitudinal data collected via wearable devices and smart phone-based ecological momentary assessment. The primary hypothesis is that there are associations between individually experienced temperature and the identified behaviors and outcomes.
Objectives:
Primary:
To explore within and between-person associations between individually experienced temperature and cardiometabolic risk behaviors and outcomes.
Secondary:
Aim 1: Explore disparities in individually experienced temperature based on race, ethnicity, socioeconomic factors, sex, and age.
Aim 2: Explore multilevel determinants of individually experienced temperature: neighborhood environment (residential and activity space), home, workplace, and preferences
Endpoints:
Primary:
- Physical Activity
- Sedentary behavior
- Stress/mental well-being
- Sleep quantity
- Sleep quality
Secondary:
- Daily mean individually experienced temperature
- Daily maximum individually experienced temperature
- Daily degree minutes above threshold
- Longest daily exposure period
- Conditions
- Temperature
- Keywords
- Physical Activity, Observational Study, Sleep, Climate Change, Cardiometabolic Risk Behaviors and Outcomes, Stress/mental well-being, Neighborhoods, TEMPERATURE
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers with home address in Washington, DC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Daily/Weekly Minutes MVPA (Moderate to Vigorous Physical Activity) as measured via waist-worn acceleromter
Measured: 2 weeks
Sedentary Behavior
Daily/Weekly Minutes Sedentary Behavior as measured via waist-worn accelerometer
Measured: 2 weeks
Stress/mental Well-being
Momentary/Daily Mean/Weekly Mean score on ecological momentary assessment random prompt questions derived from PSS-4 stress survey
Measured: 2 weeks
Sleep Quantity
Daily/Weekly Mean Hours Sleep collected via daily ecological momentary assessment morning prompt
Measured: 2 weeks
Sleep Quality
Daily/Weekly Mean Score derived from PSQI sleep survey collected via daily ecological momentary assessment morning prompt
Measured: 2 weeks
Secondary outcomes (4)
Daily mean individually experienced temperature
average of all daily minute-epoch individual environmental temperature measures collected via iButton Hygrochron aggregated to (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
Measured: 2 weeks
Daily maximum individually experienced temperature
highest measured minute-epoch individual environmental temperature collected via iButton Hygrochron for (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
Measured: 2 weeks
Daily degree minutes above threshold
minutesXdegrees exceeding test thresholds ranging from 80F-105F collected via iButton Hygrochron for (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
Measured: 2 weeks
Longest daily exposure period
minutes of longest daily period exceeding test thresholds ranging from 80F-105F collected via iButton Hygrochron for (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start22 Jul 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: Departure of key research team members.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TemperatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Kelly K Jones, Principal investigator, National Institute on Minority Health and Health Disparities (NIMHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778252
- Sponsor's protocol ID
- 10002097
- Other IDs
- 002097-MD
- Status last verified
- Jul 2025
- First submitted
- 15 Jan 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated, non-identifiable data will be submitted to a data repository as required by policy.
Publications
Beyer KMM, Szabo A, Hoormann K, Stolley M. Time spent outdoors, activity levels, and chronic disease among American adults. J Behav Med. 2018 Aug;41(4):494-503. doi: 10.1007/s10865-018-9911-1. Epub 2018 Jan 30.
PubMed 29383535Tran Trong T, Riera F, Rinaldi K, Briki W, Hue O. Ingestion of a cold temperature/menthol beverage increases outdoor exercise performance in a hot, humid environment. PLoS One. 2015 Apr 9;10(4):e0123815. doi: 10.1371/journal.pone.0123815. eCollection 2015.
PubMed 25856401Kuras ER, Richardson MB, Calkins MM, Ebi KL, Hess JJ, Kintziger KW, Jagger MA, Middel A, Scott AA, Spector JT, Uejio CK, Vanos JK, Zaitchik BF, Gohlke JM, Hondula DM. Opportunities and Challenges for Personal Heat Exposure Research. Environ Health Perspect. 2017 Aug 1;125(8):085001. doi: 10.1289/EHP556.
PubMed 28796630McGregor GR, Vanos JK. Heat: a primer for public health researchers. Public Health. 2018 Aug;161:138-146. doi: 10.1016/j.puhe.2017.11.005. Epub 2017 Dec 28.
PubMed 29290376Song X, Wang S, Hu Y, Yue M, Zhang T, Liu Y, Tian J, Shang K. Impact of ambient temperature on morbidity and mortality: An overview of reviews. Sci Total Environ. 2017 May 15;586:241-254. doi: 10.1016/j.scitotenv.2017.01.212. Epub 2017 Feb 7.
PubMed 28187945Waugh DW, He Z, Zaitchik B, Peng RD, Diette GB, Hansel NN, Matsui EC, Breysse PN, Breysse DH, Koehler K, Williams D, McCormack MC. Indoor heat exposure in Baltimore: does outdoor temperature matter? Int J Biometeorol. 2021 Apr;65(4):479-488. doi: 10.1007/s00484-020-02036-2. Epub 2020 Oct 21.
PubMed 33089367White-Newsome JL, Sanchez BN, Jolliet O, Zhang Z, Parker EA, Dvonch JT, O'Neill MS. Climate change and health: indoor heat exposure in vulnerable populations. Environ Res. 2012 Jan;112:20-7. doi: 10.1016/j.envres.2011.10.008. Epub 2011 Nov 8.
PubMed 22071034Xiang J, Bi P, Pisaniello D, Hansen A. Health impacts of workplace heat exposure: an epidemiological review. Ind Health. 2014;52(2):91-101. doi: 10.2486/indhealth.2012-0145. Epub 2013 Dec 21.
PubMed 24366537Zuurbier M, van Loenhout JAF, le Grand A, Greven F, Duijm F, Hoek G. Street temperature and building characteristics as determinants of indoor heat exposure. Sci Total Environ. 2021 Apr 20;766:144376. doi: 10.1016/j.scitotenv.2020.144376. Epub 2020 Dec 26.
PubMed 33421789
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UrbanHEAT: Pilot of Prospective Observational Study of Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
- ClinicalTrials.gov ID
- NCT06778252
- Acronym / sponsor ID
- 10002097
- Conditions
- Temperature
- Keywords
- Physical Activity, Observational Study, Sleep, Climate Change, Cardiometabolic Risk Behaviors and Outcomes, Stress/mental well-being, Neighborhoods, TEMPERATURE
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Departure of key research team members.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are conducting a research study to learn about how individuals living in Washington, DC perceive and experience temperature.
Participation in this study will include:
2 remote visits over the phone and/or computer (these will each last about1.5 to 2 hours)
- During the remote visits, you will be asked to respond to a series of surveys, so that we can learn about your life, behaviors, and health 2 weeks of data collection where you will be asked to:
- Wear monitoring devices
- These will collect information on your location and physical activity
- We will ask you to wear the monitors on a belt around your waist all day every day during these 2 weeks of data collection.
- All of the monitors will be sent to you in the mail.
- Leave a temperature tracker near where you sleep to measure the temperature of your environment.
- Use a phone app
- We will also send you questions through the phone app that will ask about your stress level, sleep duration, sleep quality, and how you feel about the current temperature.
Risks of participating in this study are minimal. They include the inconvenience of wearing the monitors and the possibility of a breach of your confidentiality. We are collecting personal information about you and the location monitor will collect information about where you spend your time. We will take every precaution in order to safeguard the data that you provide, including limiting who has access to it, storing it safely, and removing the capacity to identify you individually, as much as possible.
You will receive no immediate benefits from participating in this study. We hope what we learn will help us to develop policies and programs to help keep urban populations safe during increasingly warm summer temperatures.
You are eligible for this study if you are 18 years of age or older, live in Washington, DC, can read and write in English, and have access to a smartphone that you can use for the 2 week data collection period....
Detailed description
Study Description:
This pilot study will test measures for cardiometabolic behaviors and outcomes (e.g., physical activity, sedentary behavior, stress, sleep quality, sleep quantity) and individually experienced temperature with intensive longitudinal data collected via wearable devices and smart phone-based ecological momentary assessment. The primary hypothesis is that there are associations between individually experienced temperature and the identified behaviors and outcomes.
Objectives:
Primary:
To explore within and between-person associations between individually experienced temperature and cardiometabolic risk behaviors and outcomes.
Secondary:
Aim 1: Explore disparities in individually experienced temperature based on race, ethnicity, socioeconomic factors, sex, and age.
Aim 2: Explore multilevel determinants of individually experienced temperature: neighborhood environment (residential and activity space), home, workplace, and preferences
Endpoints:
Primary:
- Physical Activity
- Sedentary behavior
- Stress/mental well-being
- Sleep quantity
- Sleep quality
Secondary:
- Daily mean individually experienced temperature
- Daily maximum individually experienced temperature
- Daily degree minutes above threshold
- Longest daily exposure period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers with home address in Washington, DC. |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 and over with home addresses located within Washington, DC.
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Aged at least 18 years.
- Ability to read and write in English. This is justified by the novelty of the survey instruments (e.g., momentary thermal comfort conducted in an ecological momentary assessment context).
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Requirement of hospitalization at enrollment.
- Inability to consent.
- Unwillingness to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity
Time frame: 2 weeks
Daily/Weekly Minutes MVPA (Moderate to Vigorous Physical Activity) as measured via waist-worn acceleromter
Sedentary Behavior
Time frame: 2 weeks
Daily/Weekly Minutes Sedentary Behavior as measured via waist-worn accelerometer
Stress/mental Well-being
Time frame: 2 weeks
Momentary/Daily Mean/Weekly Mean score on ecological momentary assessment random prompt questions derived from PSS-4 stress survey
Sleep Quantity
Time frame: 2 weeks
Daily/Weekly Mean Hours Sleep collected via daily ecological momentary assessment morning prompt
Sleep Quality
Time frame: 2 weeks
Daily/Weekly Mean Score derived from PSQI sleep survey collected via daily ecological momentary assessment morning prompt
4 secondary outcomes
Daily mean individually experienced temperature
Time frame: 2 weeks
Daily maximum individually experienced temperature
Time frame: 2 weeks
Daily degree minutes above threshold
Time frame: 2 weeks
Longest daily exposure period
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 29383535Beyer KMM, Szabo A, Hoormann K, Stolley M. Time spent outdoors, activity levels, and chronic disease among American adults. J Behav Med. 2018 Aug;41(4):494-503. doi: 10.1007/s10865-018-9911-1. Epub 2018 Jan 30.
- Background: PubMed 25856401Tran Trong T, Riera F, Rinaldi K, Briki W, Hue O. Ingestion of a cold temperature/menthol beverage increases outdoor exercise performance in a hot, humid environment. PLoS One. 2015 Apr 9;10(4):e0123815. doi: 10.1371/journal.pone.0123815. eCollection 2015.
- Background: PubMed 28796630Kuras ER, Richardson MB, Calkins MM, Ebi KL, Hess JJ, Kintziger KW, Jagger MA, Middel A, Scott AA, Spector JT, Uejio CK, Vanos JK, Zaitchik BF, Gohlke JM, Hondula DM. Opportunities and Challenges for Personal Heat Exposure Research. Environ Health Perspect. 2017 Aug 1;125(8):085001. doi: 10.1289/EHP556.
- Background: PubMed 29290376McGregor GR, Vanos JK. Heat: a primer for public health researchers. Public Health. 2018 Aug;161:138-146. doi: 10.1016/j.puhe.2017.11.005. Epub 2017 Dec 28.
- Background: PubMed 28187945Song X, Wang S, Hu Y, Yue M, Zhang T, Liu Y, Tian J, Shang K. Impact of ambient temperature on morbidity and mortality: An overview of reviews. Sci Total Environ. 2017 May 15;586:241-254. doi: 10.1016/j.scitotenv.2017.01.212. Epub 2017 Feb 7.
- Background: PubMed 33089367Waugh DW, He Z, Zaitchik B, Peng RD, Diette GB, Hansel NN, Matsui EC, Breysse PN, Breysse DH, Koehler K, Williams D, McCormack MC. Indoor heat exposure in Baltimore: does outdoor temperature matter? Int J Biometeorol. 2021 Apr;65(4):479-488. doi: 10.1007/s00484-020-02036-2. Epub 2020 Oct 21.
- Background: PubMed 22071034White-Newsome JL, Sanchez BN, Jolliet O, Zhang Z, Parker EA, Dvonch JT, O'Neill MS. Climate change and health: indoor heat exposure in vulnerable populations. Environ Res. 2012 Jan;112:20-7. doi: 10.1016/j.envres.2011.10.008. Epub 2011 Nov 8.
- Background: PubMed 24366537Xiang J, Bi P, Pisaniello D, Hansen A. Health impacts of workplace heat exposure: an epidemiological review. Ind Health. 2014;52(2):91-101. doi: 10.2486/indhealth.2012-0145. Epub 2013 Dec 21.
- Background: PubMed 33421789Zuurbier M, van Loenhout JAF, le Grand A, Greven F, Duijm F, Hoek G. Street temperature and building characteristics as determinants of indoor heat exposure. Sci Total Environ. 2021 Apr 20;766:144376. doi: 10.1016/j.scitotenv.2020.144376. Epub 2020 Dec 26.
- Individual participant dataSharing planned: No. Aggregated, non-identifiable data will be submitted to a data repository as required by policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly K Jones principal investigator
National Institute on Minority Health and Health Disparities (NIMHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778252, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.